DJO Humeral Fracture Brace (Over The Shoulder) User Guide

DJO Humeral Fracture Brace (Over The Shoulder) User Guide

BEFORE USING THE DEVICE, PLEASE READ THE FOLLOWING INSTRUCTIONS COMPLETELY AND CAREFULLY. CORRECT APPLICATION IS VITAL TO THE PROPER FUNCTIONING OF THE DEVICE.

INTENDED USER PROFILE

The intended user should be a licensed medical professional, the patient or the patient’s caregiver. The user should be able to read, understand and be physically capable of performing the directions, warnings and cautions in the information for use.

INTENDED USE/INDICATIONS

The Procare Humeral Fracture Brace (Over the Shoulder) is designed to provide support to the humerus following stable humeral diaphyseal fractures, prophylactic application after removal of internal fixation. Soft-good/semi-rigid designed to restrict motion through elastic or semi-rigid construction.

CONTRAINDICATIONS

  • None

APPLICATION INSTRUCTIONS

  1. Sit down in a chair. Place the stockinette over the upper arm so it extends over the shoulder. Fig 1
  2. Loosen the two hook and loop straps on the brace. Place the long shoulder strap around your neck. Fig 2 Slide the brace on your arm up to your shoulder. Fig 3
  3. The cap of the brace should fit comfortably over the shoulder. Tighten straps beginning with the strap closest to the elbow then the upper strap. The straps should be cinched to produce a snug, comfortable fit. Fig 4
  4. Once the two straps on the brace are snug, loop the long strap located at the top of the brace under the uninjured arm. Fig 5
  5. Straps should be adjusted throughout the day to ensure the snug fit is properly maintained.

Fitting Chart

Size

Biceps Circumference

Brace Length

Small

8″ – 11″

11″

Medium

11″ – 14″

12.5″

Large

12″ – 15″

13.5″

X-Large

15″- 16″

14″

WARNINGS AND CAUTIONS

  • If you develop an allergic reaction and/or experience itchy, red skin after coming into contact with any part of this device, please stop using it and contact your healthcare professional immediately.
  • Excessive tightening of the brace straps may compromise circulation. If tingling or numbness is experienced, loosen straps.
  • Do not use over open wounds.
  • If pain, swelling, changes in sensation or other unusual reactions occur while using this product, you should contact your medical professional immediately.
  • Do not use this device if it is damaged and/or the packaging has been opened.

NOTE: Contact manufacturer and competent authority in case of a serious incident arising due to usage of this device.

USE AND CARE

  • Remove the brace while seated.
  • The brace may be washed using a mild detergent in warm water. Rinse thoroughly and towel dry.
  • The stockinette may be washed in warm water with a mild detergent. After thorough rinsing, allow the stockinette to air dry.
  • Be sure you bathe with the brace on. Once you have dried off and are seated  then: remove the brace, dry it off, apply a dry stockinette, reapply the brace.

WARRANTY

DJO, LLC will repair or replace all or part of the unit and its accessories for material or workmanship defects for a period of six months from the date of sale.

Rx ONLY.INTENDED FOR SINGLE PATIENT USE

NOT MADE WITH NATURAL RUBBER LATEX

MDSS GmbHSchiffgraben 4130175 HannoverGermany

DJO, LLC1430 Decision StreetVista, CA 92081-8553 USA

 

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